A Phase 2 interventional study of bosentan and Placebo in Hepatopulmonary Syndrome and Liver Cirrhosis, sponsored by Medical University of Vienna. Terminated at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-28.
Sponsored by Medical University of Vienna · Phase 2, Interventional, and Treatment
The most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is the hepatopulmonary syndrome (HPS) with a reported prevalence of 20-47% in patients with hepatic impairment and cirrhosis. HPS is by far the most frequent respiratory complication of cirrhosis. It is a progressive disease leading to significantly increased mortality. Up to date, the only therapeutic option is liver transplantation. The study hypothesis is that administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of HPS according to the ERS task force criteria will be included in this block randomized, double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with placebo). Patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8 weeks or placebo. The duration of the treatment phase of the study is 12 weeks. The primary endpoint is the alteration of gas exchange after 3 months of therapy. The expected duration of the study is 2 years.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's enrollment of 6 is below the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive placebo tablets twice daily for 3 months.
Drug: Placebo
pts. will receive bosentan for 3 months
Drug: bosentan
pts. will receive bosentan for 3 months
pts. will receive placebo for 3 months
alveolar-arterial oxygen gradient in mmHg
Time frame: 3 months
presence of HPS
assessment via contrast enhanced transthoracic echocardiography and pulmonary function testing
Time frame: 3 months
6 minutes walking distance in m
Time frame: 3 months
WHO functional class
Time frame: 3 months
quality of life
we will us the CAT-questionaire for QoL assessment
Time frame: 3 months
aminotransferase level (ASAT, ALAT)
Assessment of the aminotransferase levels in U/L
Time frame: 3 months
exhanled nitric oxide in parts per billion
Time frame: 3 months
hepatic venous pressure gradient (HVPG) in mmHg
HVPG will be assessed after inclusion in the study and after 3 months
Time frame: 3 months
pulmonary hemodynamics
pulmonary hemodynamics will be assessed after inclusion and after 3 months
Time frame: 3 months
mean arterial blood pressue in mmHg
Time frame: 3 months
partial pressure of arterial oxygen in mmHg
Time frame: 3 months
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Medical University of Vienna